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The PathLoc-C Posterior Cervical Fixation System is intended to provide immobilization of spinal segments as an adjunct to following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The PathLoc-C Posterior Cervical Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The PathLoc-C Posterior Cervical Fixation System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of polyscrews, straight rods, curved rods and set screw that can be used via an open surgical approach.

The provided text describes a medical device, the PathLoc-C Posterior Cervical Fixation System, and its 510(k) summary for FDA clearance. It focuses on demonstrating substantial equivalence to predicate devices through mechanical testing. However, it does not contain the specific information requested in the prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or human-in-the-loop performance for AI/ML device evaluation.

Therefore, I cannot provide the requested information from the given text. The document is a regulatory submission for a physical medical implant, not an AI/ML diagnostic or prognostic device that would involve the kind of performance studies, expert consensus, and ground truth establishment described in your prompt.

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